Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283
EFSA Journal · 29 authors
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This EFSA opinion evaluates the safety of a carotenoid-rich extract from yellow/orange tomatoes as a novel food. The Panel concluded that safety could not be established because the proposed uses would lead to exceedance of the acceptable daily intake (ADI) for lycopene when combined with existing dietary exposure, and because adequate safety data on the predominant carotenoids (phytoene and phytofluene) were lacking. The clinical significance is that the novel food cannot be authorized for the EU market under the proposed conditions of use.
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**Background:** Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on yellow/orange tomato extract as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant, Lycored Ltd, submitted an application on 2 March 2021 to authorize the placing on the Union market of this carotenoid-rich extract. The NF is produced from the pulp of yellow/orange tomatoes (Lycopersicon esculentum Mill.) using supercritical CO2 extraction. It is predominantly composed of lipids (>96%) and contains 10–30% carotenoids, mainly phytoene and phytofluene (5–22 g/100 g), with lesser amounts of zeta-carotene (2–7 g/100 g), lycopene (0.1–5 g/100 g), and beta-carotene (0.1–0.6 g/100 g). The applicant proposed uses in cereal bars (maximum 286 mg NF/100 g), functional drinks (maximum 40 mg NF/100 g), and as a food supplement (maximum 100 mg/day) for individuals above 15 years of age.
**Methods:** The assessment followed the EFSA guidance on NF applications and the principles of relevant EFSA Scientific Committee guidance documents. The evaluation was based on data supplied in the application, information submitted following EFSA's requests for supplementary information, and additional literature retrieved by EFSA. EFSA performed an intake assessment using the EFSA Dietary Exposure (DietEx) Tool based on individual data from the EFSA Comprehensive European Food Consumption Database. The applicant provided two genotoxicity studies (bacterial reverse mutation test and in vitro micronucleus test), a pharmacokinetic study in 24 healthy volunteers, and two human studies involving 66 and 63 subjects. No 90-day subchronic toxicity study was provided for the NF itself.
**Key Results:** The estimated P95 intakes of the NF from cereal bars and functional drinks were 1.25 mg/kg bw/day for children (3 to <10 years), 1.39 mg/kg bw/day for adolescents (10 to <18 years), and 1.72 mg/kg bw/day for adults (≥18 years). At the maximum proposed specification limit for lycopene (5% in the NF), these intakes would correspond to 0.063, 0.069, and 0.086 mg lycopene/kg bw/day, representing 12.6%, 13.8%, and 17.2% of the ADI for lycopene (0.5 mg/kg bw/day), respectively. However, the Panel noted that according to EFSA's latest exposure assessment for lycopene as a food additive (EFSA ANS Panel, 2017), the ADI was already exceeded by both the highest estimated mean and P95 intakes in children below 10 years of age, and by the highest P95 intakes in children aged 10–17 years, without considering the NF. For adults, combining the highest P95 estimates for lycopene from food color use plus high estimates from natural occurrence would reach or exceed the ADI. The estimated intakes of the NF would lead to further exceedance of the ADI. Regarding phytoene and phytofluene, the combined content in raw yellow/orange tomatoes was approximately 11 mg/100 g, compared to about 1.5–1.8 mg/100 g in red tomatoes. Consumption of 100 mg NF as a food supplement would provide up to 22 mg/day of phytoene+phytofluene, approximately 10 times higher than estimated exposure from natural occurrence (2.0 mg phytoene and 0.7 mg phytofluene per day in Luxembourg; 1.89 mg phytoene and 0.47 mg phytofluene per day in Spain). No Health-Based Guidance Value has been established for these compounds. The genotoxicity studies showed no mutagenic or clastogenic/aneugenic potential. The Panel considered the human studies of limited value for safety assessment due to study design limitations and lack of investigated safety parameters beyond reported adverse events.
**Clinical Implications:** The Panel concluded that the safety of the yellow/orange tomato extract as a novel food has not been established under the proposed conditions of use. This conclusion was based on two main factors: (1) the absence of safety data regarding phytoene and phytofluene intake from the NF, and (2) the contribution of the NF to estimated high daily intakes of lycopene, which would lead to exceedance of the established ADI when considering natural occurrence and exposure to lycopene from its use as a food additive. The Panel noted that the NF cannot be considered nutritionally advantageous and that it cannot be established whether consumption would be nutritionally disadvantageous. The opinion effectively prevents the authorization of this novel food for the EU market under the proposed uses and use levels.